This application relates to headwear for use by a sleep apnea patient. The invention serves to position airway tubes of a nasal interface operatively connected to a positive airway pressure device used in the treatment of sleep apnea. The invention is especially applicable for use with the NASAL-AIRE® interface sold by Innomed Technologies of Boca Raton, Fla. In alternative applications, the invention may be used in combination with any other medical device, such as that designed to provide mechanical respiration assistance in the treatment of congestive heart failure, emphysema, and other respiratory conditions.
Sleep apnea is a serious, potentially life-threatening breathing disorder characterized by brief interruptions of breathing during sleep. In a given night, the number of involuntary breathing pauses or “apneic events” may be as high as 20 to 30 or more per hour. These breathing pauses are almost always accompanied by snoring between apnea episodes, although not everyone who snores has this condition. Sleep apnea can also be characterized by choking sensations. The frequent interruptions of deep, restorative sleep often lead to early morning headaches and excessive daytime sleepiness.
Certain mechanical and structural problems in the airway cause the interruptions in breathing during sleep. In some people, apnea occurs when the throat muscles and tongue relax during sleep and partially block the opening of the airway. When the muscles of the soft palate at the base of the tongue and the uvula relax and sag, the airway becomes blocked, making breathing labored and noisy and even stopping it altogether. Sleep apnea also can occur in obese people when an excess amount of tissue in the airway causes it to be narrowed. With a narrowed airway, the person continues his or her efforts to breathe, but air cannot easily flow into or out of the nose or mouth. Unknown to the person, this results in heavy snoring, periods of no breathing, and frequent arousals causing abrupt changes from deep sleep to light sleep.
During the apneic event, the person is unable to breathe in oxygen and to exhale carbon dioxide, resulting in low levels of oxygen and increased levels of carbon dioxide in the blood. The reduction in oxygen and increase in carbon dioxide alert the brain to resume breathing and cause an arousal. With each arousal, a signal is sent from the brain to the upper airway muscles to open the airway; breathing is resumed, often with a loud snort or gasp. Frequent arousals, although necessary for breathing to restart, prevent the patient from getting enough restorative, deep sleep.
The specific therapy for sleep apnea is tailored to the individual patient based on medical history, physical examination, and the results of polysomnography. Medications are generally not effective in the treatment of sleep apnea. Dental appliances that reposition the lower jaw and the tongue have been helpful to some patients with mild sleep apnea. Possible side effects include damage to teeth, soft tissues, and the jaw joint. Some patients with sleep apnea may need surgery. Although several surgical procedures are used to increase the size of the airway, none of them is completely successful or without risks. More than one procedure may need to be tried before the patient realizes any benefits.
Positive ventilation therapy is the most common effective treatment for sleep apnea. Nasal continuous positive airway pressure, or “CPAP”, is the treatment of choice for most people with obstructive and mixed apnea. Hundreds of thousands of CPAP devices are currently available for treating sleep apnea. Bi-level positive airway pressure is a variation on CPAP. Instead of providing air at a constant, steady pressure all night, the machine “senses” how much air a person needs, based on inspiration and expiration, and varies its level of pressure accordingly. As a further alternative, several manufacturers have begun to offer a new generation of responsive or “smart” devices. These devices incorporate flow and pressure sensors and automatic regulation systems.
In each of the above treatment devices, a flexible hose or tubing provides a ventilation conduit interconnecting the device and an airway passage of the patient. According to one popular commercial product, the ventilation tubing is secured to the patient using a face mask and harness assembly worn on the head. This product is bulky, cumbersome, and generally uncomfortable to wear while sleeping.
The NASAL-AIRE® product by Innomed represents a substantial improvement over this prior art. The NASAL-AIRE® product utilizes a hollow under-nose reservoir which extends across the upper lip of the patient, and has two soft nasal insert sleeves for positioning in the nares of the nose. Flexible tubing connects to opposite ends of the nasal reservoir and conveniently drapes over the patient's ears to stabilize the reservoir under the nose. The opposite ends of the tubing are connected to a Y-shaped coupling. The coupling forms a single ventilation opening which connects to a main supply line of the treatment device. Using the NASAL-AIRE® product, the patient is free to talk, eat, drink, watch TV, and wear eyeglasses. While the product is especially designed and marketed for use without separate retaining means, the loose flexible tubing often becomes malpositioned and/or pinned between the patient's head and pillow during sleep. At a minimum, this can be an annoyance to the patient and in some cases may obstruct proper airflow to one or both nostrils.